11 results · 21ms · Sources: EU EUDAMED, US FDA

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SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH)

FDA 510(k)
FDA Class 2 ·Cardiovascular

DW 276 #3

FDA 510(k)
FDA Class 2 ·Dental

5MM, 33CM PEEK MONOPOLAR HANDLE 33CM

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code KOG·April 29, 2013

INSYNC III

FDA Adverse Event
Death ·MEDTRONIC S.A.·Product code DXY·May 10, 2011

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 29, 2008

PEDIATRIC LCP(TM) HIP PLATE 3.5MM 120°

FDA Adverse Event
Injury ·SYNTHES RARON·Product code HRS·September 18, 2015

BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·September 22, 2023

PHOTOFIX PATCH - 6CM X 8CM

FDA Adverse Event
Injury ·CRYOLIFE, INC. - KENNESAW·Product code PSQ·January 12, 2021

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012